| Primary Device ID | B046220102104 |
| NIH Device Record Key | 53f7cf8f-a946-4733-8783-c6619844d1fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Symmetric TK Femoral Component |
| Version Model Number | 4RT |
| Catalog Number | 22-01-02104 |
| Company DUNS | 169289308 |
| Company Name | SIGNAL MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B046220102104 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-01 |
| Device Publish Date | 2019-03-22 |
| B046220102104 | 4RT Symmetric TK Femoral Component |
| B0462201021050 | 5RT Symmetric TK Femoral Component |
| B0462201020070 | 7LT Symmetric TK Femoral Component |
| B0462201020060 | Symmetric TK Femoral Component 6LT |
| B0462201020050 | 5LT Symmetric TK Femoral Component |
| B0462201020040 | 4LT Symmetric TK Femoral Component |
| B0462201021030 | 3RT Symmetric TK Femoral Component |
| B0462201020030 | 3LT Symmetric TK Femoral Component |